MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION 8CH INFINITY DBS LEAD KIT, 30CM, 0.5, B

Model Number 6170

Device Problem Material Fragmentation (1261)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/02/2020

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided on the final report.During processing of this incident, attempts were made to obtain complete device information.Date of the event is estimated.

Event Description

Related manufacturer report number 1627487-2020-22934.It was reported that during a lead explant procedure, physician was unable to explant the entire lead and a partial of the lead remains subcutaneously implanted in the brain tissue.It is unknown which lead had the issue therefore both leads are being reported.A new lead was successfully implanted.Patient was stable.

Manufacturer Narrative

The allegation that part of the lead remained implanted in the patient was not confirmed.This issue cannot be confirmed with product testing.The lead was returned cut and incomplete and could not be fully analyzed.Ten cm of the middle segment was missing.Per the event details, the lead had to be cut while attempting to explant it, due to part of it being firmly secured by scar tissue on the skull.Visual inspection did not identify any anomaly or damage that existed prior to explant.The root cause of the issue could not be definitively determined.

• Brand Name: 8CH INFINITY DBS LEAD KIT, 30CM, 0.5, B
• Type of Device: DBS LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 10292307
• MDR Text Key: 199454478
• Report Number: 1627487-2020-22589
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 05415067020642
• UDI-Public: 05415067020642
• Combination Product (y/n): N
• PMA/PMN Number: P140009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 09/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/23/2021
• Device Model Number: 6170
• Device Catalogue Number: 6178
• Device Lot Number: 6848323
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DBS LEAD
• Patient Outcome(s): Other